Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00710515
First received: July 2, 2008
Last updated: December 9, 2010
Last verified: December 2010
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Purpose
The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Malignant Melanoma |
Drug: AZD6244 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open-Label Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To assess whether food influences the rate and extent of AZD6244 absorption [ Time Frame: Day 1 and Day 10 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food [ Time Frame: Day 1, 2, 3, 8, 9, and 10 ] [ Designated as safety issue: Yes ]
- To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies [ Time Frame: screening to 30 day post last dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | July 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
with food
|
Drug: AZD6244
75mg
|
|
Experimental: 2
without food
|
Drug: AZD6244
75mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Able to eat a high fat breakfast within a 30-minute period
- Advanced cancer which is refractory to standard therapies, for which no standard therapies exist
- WHO or ECOG performance status 0-2 (those with performance status 2 must have been stable with no deterioration for over 2 weeks)
Exclusion Criteria:
- Any radiotherapy or chemotherapy within 21 days prior to starting the study treatment (not including palliative radiotherapy at focal sites).
- Any evidence of severe or uncontrolled systemic disease (eg., severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy.
- Refractory nausea and vomiting, chronic GI diseases (eg., inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710515
Locations
| Netherlands | |
| Research Site | |
| Amsterdam, Netherlands | |
| Research Site | |
| Maastricht, Netherlands | |
| United Kingdom | |
| Research Site | |
| Glasgow, United Kingdom | |
| Research Site | |
| Headington, United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| Research Site | |
| Oxford, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Rajesh Chopra | AstraZeneca |
| Principal Investigator: | Jan Schellens | Maastricht |
More Information
No publications provided
| Responsible Party: | Rajesh Chopra, MD, Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00710515 History of Changes |
| Other Study ID Numbers: | D1532C00020, 2007-004456-37 EudraCT Number |
| Study First Received: | July 2, 2008 |
| Last Updated: | December 9, 2010 |
| Health Authority: | Netherlands: Medicines Evaluation Board (MEB) United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
Melanoma Phase I AZD6244 |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 22, 2013